Phase 2 study of Linaclotide as a novel treatment for minimal Hepatic Encephalopathy.
Phase 2
Recruiting
- Conditions
- Chronic liver disease/ Liver cirrhosis / minimal hepatic encephalopathy
- Registration Number
- JPRN-jRCTs031200163
- Lead Sponsor
- ogami Asako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Liver cirrhosis patients with minimal hepatic encephalopathy
Exclusion Criteria
patients having hypersensitivity to Linaclotide
a past history of bowel obstruction or peritonitis
comorbidity of psychiatric disorder such as depression, masked depression, schizophrenia and dementia.
patients recieving antibiotics within a week before starting Linaclotide.
patients having active gastrointestinal bleeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of number connection test-A
- Secondary Outcome Measures
Name Time Method Improvement of number connection test-B<br>serum ammonia level<br>flapping tremor<br>hepatic encephalopathy coma (West Haven Criteria)<br>PSE index<br>rate of change of PSE index<br>bowel movement frequency, levels of consiousness<br>general effectiveness evaluation